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Glioblastoma MultiformePhase 2NCT01071837

APG101 in Glioblastoma

A Phase 2 study testing APG101 and Blood drawing in people with Glioblastoma Multiforme, run by Apogenix GmbH at 21 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase II study of APG101 + reirradiation (RT) versus reirradiation. Patients suffering from a malignant brain tumor called glioblastoma having a first or second progression can be included. They will be randomized to RT or RT + APG101. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma Multiforme
What is being tested?
APG101 and Blood drawing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
21 sitesin 2 countries
Study dates
Dec 2009to Oct 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female patients with a recurrence / progression of glioblastoma either not being eligible for tumour resection or having macroscopic residual tumour after resection of the recurrence
  • Diagnosis of glioblastoma must be proven histologically and progress must be documented by MRI. MRI images must not be older than 2 weeks before first dosing/start of RT
  • Not more than two prior therapy regimens including one or two resections, one or two chemotherapies of which one must have been TMZ-containing and one radiotherapy (RT) for the brain tumour
  • Previous irradiation therapy of the primary tumour with a maximal dose of 60 Gy; at least 8 months since the end of preirradiation
  • Candidate for reirradiation with recurrent tumour visible on MRI-T1 (Gd) and with the largest diameter measuring 1 cm to 4 cm
  • Informed consent
Show all 11Show fewer
  • Age at least 18 years, smoking or non-smoking, of any ethnic origin
  • Karnofsky performance index (KPI) ≥ 60%
  • Neutrophile counts > 1500/μl / Platelet counts > 80.000/μl / Haemoglobin > 10 g/dl / Serum creatinine < 1.5-fold upper normal range / Bilirubin, AST or ALT < 2,5-fold upper normal range unless attributed to anticonvulsants / Alkaline phosphatase < 2,5-fold upper normal range
  • Adequate contraception
  • Stable or decreasing treatment with steroids within 5 days before treatment start

Who cannot join

  • More than one RT of brain, prior first radiotherapy with more than 60 Gy
  • Cumulative total dose on the optical chiasm >54 Gy for 2 Gy/fraction, α/β=2
  • Prior treatment with bevacizumab, iodine seeds and/or brachytherapy
  • Unable to undergo MRI
  • Past medical history of diseases with poor prognosis according to the judgement of the Investigator, e.g. severe coronary heart disease, severe diabetes, immune deficiency, residual deficits after stroke, severe mental retardation
  • HIV or hepatitis infection
Show all 9Show fewer
  • Pregnancy or breast feeding
  • Treatment within any other clinical trial parallel to the treatment phase of the current study or within 30 days before inclusion
  • Known active coronary artery disease, significant cardiac arrhythmias or severe congestive heart failure (NYHA class III - IV)

Trial locations and contacts

21 sites in 2 countries.

21 sites in 2 countries

Germany17 sites

  • Charite Universitätsmedizin Berlin, Klinik für Neurochirugie

    Berlin, 13353

  • Neurologische Universitätsklinik am Knappschaftskrankenhaus

    Bochum, 44892

  • Neurologische Universitätsklinik Bonn, Schwerpunkt klinische Neuroonkologie

    Bonn, 53105

  • Universitätsklinik Dresden, Klinik und Poliklinik für Neurochirurgie

    Dresden, 01307

  • Klinikum Frankfurt/Oder, Klinik für Strahlentherapie/Radioonkologie

    Frankfurt (Oder), 15236

  • Universitätsklinik Hamburg, Klinik für Neurochirugie

    Hamburg, 20246

  • Universitätsklinik Heidelberg, Abteilung Neuroonkologie

    Heidelberg, 69120

  • Universität Leipzig, Klinik für Strahlentherapie

    Leipzig, 04103

  • Universitätsmedizin Mannheim, Klinik für Neurochirurgie

    Mannheim, 68167

  • Philipps-Universität Marburg, Klinik für Neurologie

    Marburg, 35039

  • LMU München, Klinik und Poliklinik für Strahlentherapie und Radioonkologie, Campus Großhadern & Campus Innenstadt

    München, 81377

  • Klinik und Poliklinik für Strahlentherapie/Radiologische Onkologie, Klinikum rechts der Isar, TU München

    München, 81675

  • Städt. Kliniken München GmbH, Klinikum Bogenhausen, Abt. Neurochirurgie

    München, 81925

  • Klinik und Poliklinik der Universität Regensburg, Im Bezirksklinikum

    Regensburg, 93053

  • Klinikum Stuttgart, Neurozentrum Neurochirurgie

    Stuttgart, 70174

  • Universitätsklinikum Tuebingen, Strahlenonkologie

    Tübingen, 72076

  • Uniklinik Ulm, Klinik für Strahlentherapie und Radioonkologie

    Ulm, 89081

Other trials in Germany

Austria4 sites

  • Medizinische Universität Graz, Universitätsklinik für Neurologie Landeskrankenhaus Graz

    Graz, 8036

  • Universitätsklinik für Neurologie, Landeskrankenhaus Innsbruck

    Innsbruck, 6020

  • Landesnervenklinik Wagner-Jauregg, Innere Medizin mit Neuroonkologie

    Linz, 4020

  • Allgemeines Krankenhaus der Stadt Wien, Klinische Onkologie

    Vienna, 1090

Other trials in Austria

About this study

Official title: A Phase II, Randomized, Open-label, Multi-centre Study of Weekly APG101 + Reirradiation Versus Reirradiation in the Treatment of Patients With First or Second Progression of Glioblastoma

This is a phase II study of APG101 + reirradiation (RT) versus reirradiation. Patients suffering from a malignant brain tumor called glioblastoma having a first or second progression can be included. They will be randomized to RT or RT + APG101.

APG101 is a fusion protein (similar to an antibody) and will be administered as a weekly infusion. Patients can stay in this study as long as they benefit from the participation (no fixed end).

In this trial, 30-35 sites in Germany, Austria and Russia take part.

Read the detailed description

In this phase II trial, patients with a recurrence / progression of glioblastoma (first or second progression) either not being eligible for tumour resection or having macroscopic residual tumour after resection of the recurrence can be included (tumor size must 1-4 cm in T1-weighted MRI). They must be candidates for a re-irradiation and will then be randomized in a 1:2 ratio to re-irradiation alone or re-irradiation + 400mg APG101 as a weekly intravenous infusion.

Radiotherapy (RT) is considered standard of care and not a study procedure. As prior therapies, a first radiotherapy (maximal dose of 60 Gy; at least 8 months since the end of preirradiation), a prior surgery (at least for histology) and at least one Temozolomide-containing chemotherapy are mandatory; patients with prior treatment with bevacizumab, iodine seeds and/or brachytherapy are not eligible. The patients' steroid dose must be stable or decreasing upon inclusion.

The number of patients to be included in this study is up to 83 (depending on the statistical 2-step SIMON design).

Primary objective: 6 months rate of progression free survival (PFS6). Subjects can participate in this study as long as a clinical benefit is considered by the treating physician.

MRI tumour imaging will be carried out every 6 weeks.

Being tested
APG101, Blood drawing
Keywords
Glioblastoma Multiforme
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APG101Drug

    Also called Recombinant fusion protein

    400mg weekly as intravenous infusion

  • Blood drawingProcedure or surgery

    Blood drawings, e.g. for safety labs, abdominal ultrasound, ECG. Re-Irradiation is not considered a study procedure, but standard of care (inclusion criterion)

Study groups in NCT01071837
Study groupRoleWhat they receive
Re-IrradiationActive comparator33% of the patients will be randomized to reirradiation (RT) alone. They will receive 36 Gy (2 Gy per fraction)
Receives: Procedure: Blood drawing
Re-Irradiation + APG101Experimental66% of the patients will be randomized to reirradiation (RT) + 400 mg APG101 weekly. They will receive 36 Gy (2 Gy per fraction) and 400 mg APG101 weekly as an intravenous infusion
Receives: Drug: APG101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6 months rate of progression free survival (PFS6)

    Measured: 6 month

Secondary outcomes (7)

  1. Safety and tolerability of APG101

    Measured: ongoing during study

  2. Progression-free survival

    Measured: until progression of underlying disease

  3. Objective response rates (OR)

    Measured: ongoing during study

  4. Duration of response (DR) in responders

    Measured: ongoing during study

  5. Overall survival

    Measured: until study and after end of study (by 8-weekly phone calls)

  6. Quality of life

    Measured: ongoing during study

  7. Cognitive function

    Measured: ongoing during study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2010 (estimated)
  2. Study startDec 2009
  3. Primary completionOct 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01071837
Sponsor's protocol ID
APG101_CD_002
Status last verified
Jun 2015
First submitted
18 Feb 2010
Last updated
16 Jun 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing APG101 and Blood drawing in people with Glioblastoma Multiforme, run by Apogenix GmbH at 21 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6 months rate of progression free survival (PFS6) (time frame: 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01071837.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2015.

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